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The Cancer Letter Inc.
PO Box 9905
DC 20016
Tel: 202-362-1809
Fax: 202-379-1787
publication date: Feb 29, 2016
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February 2016 PDF



Phase III Blincyto Study Stopped Early After Meeting OS Primary Endpoint

A phase III study of Blincyto met its primary endpoint of overall survival in patients with acute lymphoblastic leukemia following a prespecified interim analysis. The study was stopped early.

The randomized, open-label TOWER study evaluated the efficacy of Blincyto (blinatumomab) versus the standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Patients were randomized in a 2:1 ratio to receive Blincyto or treatment with investigator choice of one of four protocol defined SOC chemotherapy regimens.


    Soft Tissue Sarcoma

    Halaven Study Improves Overall Survival In Liposarcomas and Leiomyosarcomas

    Full results from a phase III study showed improved median overall survival in unresectable locally advanced liposarcomas and leiomyosarcomas in patients receiving Halaven (eribulin), compared to dacarbazine.

    The clinical trial, study 309, included data from 452 adults, and was published in The Lancet, which also published an editorial discussing the study results.

    The study compared patients treated with eribulin mesilate (1.4 mg/msquared intravenously on days 1 and 8) and those treated with dacarbazine (850 mg/msquared, 1000 mg/msquared, or 1200 mg/msquared [dose dependent on center and clinician] intravenously on day 1). Additional endpoints included progression-free survival and quality of life.


      Breast Cancer

      OBI-822/821 Phase II/III Study Does Not Meet PFS Endpoint, But Shows Positive Results In Patients with Immune Response

      OBI Pharma Inc., announced topline results from a phase II/III study of OBI-822/821 (formerly OPT822/OPT821), which evaluated the clinical benefit and immunogenicity in patients with metastatic breast cancer. The study did not meet the primary efficacy endpoint of progression-free survival.

      However, patients who demonstrated an immune response showed highly significant improvement in progression-free survival and the secondary endpoint of overall survival is trending towards statistical significance. OBI-822/821 was generally well tolerated with no major safety concerns. Full results will be presented at an upcoming international scientific conference.


        Pancreatic Cancer

        Two Studies Evaluate 2nd Line Treatments Following Abraxane


        Non-Small Cell Lung Cancer

        Gilotrif Improves PFS Compared to Iressa in Phase IIb Trial


        Thyroid Cancer

        Study: Afirma Genomic Test Can Reduce Unnecessary Fine Needle Aspiration Biopsies


        NCI CTEP-Approved Trials for the Month of February


        Drugs and Targets

        • Gazyva Combination Approved In Follicular Lymphoma
        • FDA approves Afinitor for GI and lung NETs
        • Venetoclax receives third FDA Breakthrough Designation
        • FDA grants breakthrough designation to PKC412 (midostaurin)
        • FDA grants orphan drug designation to tazemetostat for malignant rhabdoid tumors
        • FDA grants orphan drug designation to CD101 IV for candidema

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